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KANEKA Corporation

Japan·JP-MF-000022143

Last updated May 25, 2026

Information

Country: Japan
Address: 3-18, 2-chome Nakanoshima, Osaka-city, Japan
Website: www.kaneka.co.jp/en/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +815031339235
PRRC Contact: Kazuaki Sanaka
EUDAMED SRN: JP-MF-000022143
FDA FEI Number: —
DUNS Number: 690535406

Catalogue (1026)

Page 18 of 21

Device	Model / Reference	Registries	Class	Status
Crosperio RX	BD-B40080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50040MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F40120LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60120LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L50040CR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30080MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30120MW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30080LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F50200MR	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20150MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30040MR	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L80080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L90040CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F30060LW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60100LW	EUDAMEDFDA UDI	Class IIa	Active
Raiden3	RD3-13-250	EUDAMED	Class III	Active
Metacross RX	BD-L60120CR	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P70080ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20150LR	EUDAMEDFDA UDI	Class IIa	Active
Neon	BS-12008	EUDAMED	Class III	Active
R2P Crosstella RX	BD-Q50040ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio OTW	BD-B40150SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L30080CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F30120MR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F20200LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q60040ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L70020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0060CW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20150LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L30080SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0020SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F40080LR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q60150ER	EUDAMEDFDA UDI	Class IIa	Active
Crosstella RX	BD-F25150LR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F25040LW	EUDAMEDFDA UDI	Class IIa	Active
IKAZUCHI Zero	ZE-8-275	EUDAMED	Class III	Active
Neon	BS-30020	EUDAMED	Class III	Active
Crosstella OTW	BD-F20040LW	EUDAMEDFDA UDI	Class IIa	Active
Metacross RX	BD-L40060CR	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F20200MW	EUDAMEDFDA UDI	Class IIa	Active
Senri	BD-S4040L	EUDAMED	Class IIa	Active
R2P Metacross RX	BD-P40120ER	EUDAMEDFDA UDI	Class IIa	Active
Crosperio RX	BD-B20080MR	EUDAMEDFDA UDI	Class IIa	Active
R2P Crosstella RX	BD-Q30120ER	EUDAMEDFDA UDI	Class IIa	Active
R2P Metacross RX	BD-P50020ER	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L90040SW	EUDAMEDFDA UDI	Class IIa	Active
Crosstella OTW	BD-F60040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-LX0060SW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50040MW	EUDAMEDFDA UDI	Class IIa	Active
Metacross OTW	BD-L50080CW	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Kaneka Medical Europe N.V. BE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Kaneka Corp. US